GUEST CONTRIBUTORS

  • Outsourced Manufacturing Considerations For M&A Technical Due Diligence
    Outsourced Manufacturing Considerations For M&A Technical Due Diligence

    My previous article on the regulatory and quality aspects of M&A technical due diligence looked at how to ensure you acquire products that can be outsourced properly to a third-party manufacturer. This second part will cover considerations for the manufacturing process and equipment as well as some aspects of logistics and operations.

  • Developing Mobile Continuous Process Technology:  A Collaborative Innovation Case Study
    Developing Mobile Continuous Process Technology: A Collaborative Innovation Case Study

    In Part 1 of this two-part article, we explored the role of open collaboration in the future pharmaceutical manufacturing innovation. Part 2 provides a specific example of how such collaboration is already taking place, through a unique industry-academic partnership.

  • An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities
    An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities

    Beginning in 2004, a global team of pharmaceutical toxicologists, industrial hygienists, quality assurance professionals, a cleaning validation professional, and a representative from the US FDA participated in the development of the International Society for Pharmaceutical Engineering's (ISPE) Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP) Baseline Guide.

More From Guest Contributors

PHARMA OUTSOURCING WHITE PAPERS

Reducing The Burden Of Data Collection In Oncology Trials Reducing The Burden Of Data Collection In Oncology Trials

Understanding patient reported outcomes (PROs) in oncology clinical trials enables researchers to develop more effective treatments for patients battling this illness. But if it isn't easy for patients to report their health data, they won't - so it must be accessible for them.

Broaden Analysis Of Compound Factors For Predictive Solubility Solutions Broaden Analysis Of Compound Factors For Predictive Solubility Solutions

Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.

The Future of BioManufacturing

The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.

The Role Of Pharmaceutical Packaging Partners In Times Of Growth

The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont

Customizing The Cold Chain

With things “heating up” in terms of more diverse temperature demands, the industry is moving away from the term cold chain, and we’ll start to see more references to the more inclusive temperature-controlled transport.

Four Reasons For The Rise In Blister Packaging

Blister packaging, not long ago considered a less significant segment of the North American pharmaceutical packaging industry, is now outpacing most other industry segments. In 2010, blister represented 17% of the global market and recorded $8.1B in revenue, according to Pharmaceutical Packaging Industry – 2011 Yearbook. GBI Research. By Paul Dupont, Director of Business Development North America, Ropack, Inc.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Sharing Instruments: Bottleneck Or Increasing Utilization?

Development of efficient manufacturing processes is a necessity for cost-effective production of biopharmaceuticals. By carefully designing and evaluating your experiments, sufficient information for optimizing your process can be obtained with a minimal number of experiments.

Driving Productivity In Protein Purification

Crucial to the successful operation of any research laboratory is the ability to efficiently generate purified proteins for further investigation and analysis. By Per Lidén (GE Healthcare Life Sciences), Svend Kjær (Cancer Research UK) and Mark Cooper (Abcam)

How A Big Pharma Company Quickly Transferred 2 Oral Powder Antibiotics To Another Facility

Patheon’s Puerto Rico Operations specialize in the high volume commercial manufacture of solid dosage forms including tablets, capsules, and powders packaged in bottles.

Vertex Pharmaceuticals: Document Management Strategies For R&D

Based out of South Boston, MA, with additional research programs in the UK and Canada, Vertex Pharmaceuticals has spent the past 25 years working to improve the lives of patients with serious diseases.

More Pharma Outsourcing App Notes & Case Studies

ABOUT US

Welcome to OutsourcedPharma.com, the website dedicated to pharmaceutical drug development services.

Outsourced Pharma provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and health care markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their Bio and Pharma sponsors. Outsourced Pharma is part of the Life Science Connect media group, and also a sponsor of Outsourced Pharma West conferences.

With regular sections on pharmaceutical drug development, contract manufacturing, contract research services, contract packaging services, formulation & development services, contract analytical testing, API (Active Pharmaceutical Ingredients) manufacturing, stability testing services  and other areas in pharmaceutical contract development and manufacturing, we bring complete coverage of outsourcing trends and issues to the pharmaceutical contract development and manufacturing marketplace.

Use our supplier directory and offline search service to expedite your discovery of CMOs, CDMOs, CROs, and functional service providers. Please take a moment to join our community and discover the benefits of your free membership.

The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.

Louis Garguilo Articles

INDUSTRY INSIGHTS

  • 3 Steps To Prepare For FDA’s Final Quality Metrics Guidance
    3 Steps To Prepare For FDA’s Final Quality Metrics Guidance

    Reacting to trends, including drug shortages and plant inspections that increasingly question manufacturing data integrity, FDA’s recent draft guidance Request for Quality Metrics promotes a “quality-driven corporate culture” as one of its goals.

  •  Quality Metrics: How To Add Value And Meet The FDA’s Expectations
    Quality Metrics: How To Add Value And Meet The FDA’s Expectations

    Quality metrics have been widely used in the pharma industry to monitor quality systems, operational processes, and to promote continuous improvement initiatives in drug manufacturing. However, the task of selecting the right metrics to incorporate has always been a bit of a challenge as quality can be subjective and hard to measure in a meaningful way. 

  • CDMOs — At The Core Of Next-Generation Pharma Models
    CDMOs — At The Core Of Next-Generation Pharma Models

    In today’s pharmaceutical industry, the economic strains of keeping a company completely vertically integrated are no longer feasible. Smaller, virtual drug companies simply do not have the resources necessary to translate a molecule to a drug product.

     

  • Digitally Transforming Laboratory Operations
    Digitally Transforming Laboratory Operations

    “Digital transformation” is a common buzzword across industries today, but is it more than just jargon?  Faced by shifting consumer demand, rapidly evolving technology and increasing competition, organizations — to a large extent from science-based industries — are realizing that business as usual (or only incremental change to traditional approaches) does not address today’s challenges in a sustainable, long-term way.

  • Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off
    Quality By Design In Biopharma R&D: Bringing Quality Forward Pays Off

    With biologics filling the pipelines of life sciences companies more than ever, the biopharmaceutical industry needs to rethink its view of quality. Once primarily considered a focus in downstream drug development and manufacturing, quality now demands just as much attention in upstream discovery research.

More Industry Insights

OUTSOURCING EVENTS

FDA Guidance on Medical Device Cybersecurity - Preparing for the Present and Future June 6, 2017
1pm-2:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
Selecting a CMO/CDMO: 11 Best Practices For Sourcing The Right Partner June 7, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Cell Therapy: Process Design Considerations To Support Commercialization June 13, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Environmental Monitoring (EM) – Establishing and Improving Programs Using a Risk-based Approach June 14, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Organizational Strategies for Reducing Human Error in GMP Environments June 20, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
More Industry Events